Fast-Her: Fasting Effects on Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically confirmed metastatic breast cancer
- •Menopausal or medically ovarian suppressed
- •Currently receiving capivasertib therapy (2 tablets twice daily, 4 days per week)
- •Stable on current capivasertib regimen for at least 2 weeks
- •an ECOG performance status of 0-1
- •BMI ≥25kg/m2
- •Able to provide informed consent
- •Willing to comply with study procedures including CGM wear, food tracking by mCC app and dietary modifications
- •Access to smartphone or tablet for mobile application use
排除标准
- •Type 1 diabetes mellitus
- •Uncontrolled type 2 diabetes (HbA1c >9.0%)
- •History of severe hypoglycemia
- •Eating disorders or contraindications to fasting
- •Pregnancy or breastfeeding
- •Significant gastrointestinal disorders affecting food absorption
- •Unable to fast for medical reasons
- •Concurrent participation in other dietary intervention studies
- •A history of significantly abnormal lab results within 4 weeks of consent date, such as hematologic (Hgb < 10.0, platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5)
研究组 & 干预措施
Sequence A
Participants randomized to Sequence A will complete a normal eating intervention period, followed by a washout period, followed by a prolonged fasting intervention period.
Normal eating → Washout → Prolonged fasting
干预措施: Normal Eating (Behavioral)
Sequence B
Participants randomized to Sequence B will complete a prolonged fasting intervention period, followed by a washout period, followed by a normal eating intervention period.
Prolonged fasting → Washout → Normal eating
干预措施: Normal Eating (Behavioral)
Sequence A
Participants randomized to Sequence A will complete a normal eating intervention period, followed by a washout period, followed by a prolonged fasting intervention period.
Normal eating → Washout → Prolonged fasting
干预措施: Prolonged Fasting (Behavioral)
Sequence B
Participants randomized to Sequence B will complete a prolonged fasting intervention period, followed by a washout period, followed by a normal eating intervention period.
Prolonged fasting → Washout → Normal eating
干预措施: Prolonged Fasting (Behavioral)